Departmental Resources for Research Development Beverly Collins - PowerPoint PPT Presentation

Departmental Resources for Research Development Beverly Collins Amber Nestor Erin Schubert 1

TOPICS Beverly Collins: Grant-preparation and submission Amber Nestor: Budget development Erin Schubert: Protocol development 2

Putting together a grant  I can help with:  Funding sources  Biographical sketch  Resources descriptions  Collecting letters, signatures  Information  Noodge, go-between  Proofreading 3

Submitting a Proposal  2 ways a grant may be submitted P.I. submits the grant directly to the 1. funding agency. A representative of Penn submits the 2. grant to the funding agency.  Funding agency designates which 4

Penn’s review process  EVERY external-funding proposal must be entered into Penn’s online grant application system (PennERA/PD) 5

PD (Proposal Development) 6

Penn’s review process  For non-NIH proposals, use the application provided by the funding agency and upload to PD for institution review and approval.  The funding agency will indicate whether the application is to be submitted by an institutional official.  (NIH proposals are created from the PD record; you do not use the NIH application package.) 7

Penn’s review process  I can help you set up the proposal in PD  You don’t need to enter the budget info into PD. We have people to do that for you.  Amber Nestor handles all RSNA grants and most resident proposals. 8

 The administrative (i.e. budget) part of the proposal should be submitted for Penn review 1-2 weeks before deadline. 9

RSNA Proposal Instructions  RSNA deadline: Jan 15, 2019  Penn budget deadline: Jan 8  You will need a signature from Penn 10

RSNA Signature page 11

RSNA Signature page  You will enter names of signatories to RSNA application site, then download the signature page.  You, your advisor, and the chair sign, then upload to PD.  When budget is approved, Penn rep will sign, and you can download completed page from PD and upload it to RSNA site. 12

Take-home points  Grant-writing takes time and has a lot of pieces  There is a Penn review process before submitting to sponsor  There are people here to help  Let me know as soon as you decide to apply for a grant 13

Speaking of budgets…  The First Bank of the United States 128 South 3rd Street Greek revival 14

Speaking of budgets…  The Second Bank of the United States 420 Chestnut Street Greek revival The structure is open to the public free of charge and serves as an art gallery, housing a large collection of portraits of prominent early Americans painted by Charles Willson Peale and many others. 15

Budget Amber Nestor Grant Manager 16

Budget  Contact – 6-8 weeks prior to due date  Send guidelines/funding announcements for review  Budget must be finalized 10-14 business days prior to due date 17

What should be included?  Personnel: % effort for each investigator  Imaging: how many of what kinds of scans  Supplies, equipment, animals, etc.  Travel, for presenting results  I can help with this if you are unsure!! 18

What else do you need to do?  Budget justifications – if these are required, they must have detailed information about what you’re asking for! I can send samples of justifications if you are lost!  Pay close attention to due dates for grants – specifically NIH grants! 19

Congrats! You’re funded… now what?  All funds come through Radiology  No pre-award costs are allowed, unless noted in the NOGA or award letter  Spending cannot occur prior to start date of grant  Account numbers are issued once the grant is awarded. 20

Finally….  Please DO NOT submit grants on your own!! Every grant that you apply for must have institutional review.  Some sponsors require signature pages  NIH requires submission be done by an authorized University official! 21

Protocol Development Erin Schubert Administrative Director, PET Center 22

Protocol Development  Idea  Grant  Protocol  Start planning your protocol from the beginning  Many sections of the protocol will overlap with required grant sections  IRB submission and review can take 6-8 weeks from submission to approval  IND submission can take additional time 23

Plan Your Grant  Planning for the human subjects protocol early will aid in grant preparation  Helps motivate grant aims  Developing a budget and budget justifications  Evaluating necessary staff and co- investigators requiring funding  Human subject protections write up 24

Strategic Planning  NIH grants often require IRB approval as part of JIT submissions  Avoid delays in study start up once you receive funding  Institutional opportunities may exist to start collecting pilot data prior to notice of award  Multiple UPenn regulatory committees (IRB, RRSC, CTSRMC) 25

Protocol Building Blocks  Background and Scientific Rationale  What is the purpose of the proposed research? What is the value added?  Objectives  What do you hope to learn from the proposed research?  Study Design  What is your plan for meeting the study objectives? 26

Protocol Building Blocks  Participant selection  What subject population do you plan to study?  Recruitment  How will you get access to your subject population? Does this require additional collaborators?  Investigational agent?  Does the study require an IND? 27

Protocol Building Blocks  Procedures  What research procedures will the study include? Who will perform the procedures?  Risks  Statistical Plan  How will you analyze your study results? 28

IND Considerations  Does your study involve an investigational drug?  Is the drug currently made at Penn or does it need to be developed?  Will your study require a new IND or does Penn already have an active IND? 29

IND Building Blocks  Background and Investigational Plan  Pharmacology and Toxicology  Previous Human Experience  Biodistribution and Dosimetry  Chemistry, Manufacturing and Controls  Protocol and Investigator Information 30

Key Contacts for Protocol/IND  Erin Schubert – Protocol, IND, Regulatory document development and submission  Kathleen Thomas and Patty Atkinson- Radiology IND support office, handles all IND submissions and monitoring  Sharon Lee – Cyclotron contact for development of drug synthesis, validation testing and CMC creation 31

Key Links - Research at Penn  IRB : https://hsera.apps.upenn.edu  RRSC: https://ehrs.upenn.edu/radiation- safety/topics/research  CTSRMC: http://www.ctsrmc.org/  CAMRIS: https://www.med.upenn.edu/camris/  OCR: https://www.med.upenn.edu/ocr/ 32

Key Links - Research at Penn  PennERA: https://www.pennera.upenn.edu/  RSNA grants: https://www.rsna.org/en/research/fundi ng-opportunities/research-grants  33

People in department  Beverly Collins: grant funding, proposal development  Amber Nestor: budget development  Erin Schubert: protocol development  Kathleen Thomas: research coordinator requests  Bill D’Arcy : Business Administrator for grants, pre- and post-award 34